Margaret A.WinkerMD, Deputy EditorIndividualAuthorPhil B.FontanarosaMD, Interim CoeditorIndividualAuthor
To the Editor: The clinical trial by Mr Bensoussan
and colleagues1 on CHM for IBS is an innovative
effort that respects the integrity of an alternative paradigm yet simultaneously
manages to adopt the methodological safeguards demanded by scientific research.
However, the answers to 3 questions are important in interpreting the results.
First, how was the standardized herbal formula selected or devised? My examination
of Chinese and English sources has not uncovered any similar prescription.2,3 Second, what were the exact herbs
constituting the placebo? One needs to be vigilant about the possibility of
a noninert placebo causing independent harmful or beneficial effects that
could bias the outcome of a trial.4 Because
there are no regulations for the composition of placebos, this can present
a challenge in any clinical trial,5 but
it may be especially problematic with herbal placebos. Finally, why do the
ingredients of the standard herbal formula not add up to 100%?
Kaptchuk TJ. Chinese Herbal Medicine for Irritable Bowel Syndrome. JAMA. 1999;282(11):1035-1037. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-11-jac90008